Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial
Efficacy of Inhaled Ciclesonide for Outpatient Treatment of Adolescents and Adults With Symptomatic COVID-19: A Randomized Clinical Trial
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DOI：
10.1001/jamainternmed.2021.6759
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发表时间：
2021-11-22
影响因子：
39
通讯作者：
Blaiss, Michael S.
中科院分区：
文献类型：
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作者：
Clemency, Brian M.;Varughese, Renoj;Blaiss, Michael S.
全身皮质类固醇通常用于治疗重症COVID-19。然而，吸入皮质类固醇在轻中度疾病患者治疗中的作用尚不清楚。目的探讨吸入性类固醇环莱索奈德在减少症状性COVID-19感染非住院患者所有COVID-19相关症状缓解时间方面的疗效。这项3期、多中心、双盲、随机临床试验在美国10个中心进行，评估了环来奈德计量吸入器（MDI）治疗有症状的COVID-19感染的非住院患者的安全性和有效性，这些患者于2020年6月11日至2020年11月3日进行筛查。干预措施参与者被随机分配接受环奈德MDI，每次160 μ g，总共2次，每天两次（总每日剂量，640 μ g）或安慰剂，持续30天。主要终点是在第30天之前缓解所有covid -19相关症状（咳嗽、呼吸困难、寒战、发烧、反复颤抖、肌肉疼痛、头痛、喉咙痛和新的味觉或嗅觉丧失）的时间。次要终点包括因COVID-19原因导致的急诊就诊或住院。结果：共筛选了413名参与者，400名（96.9%）被纳入并随机分配（环lesonide组197名[49.3%]，安慰剂组203名[50.7%]；平均[SD]年龄43.3[16.9]岁；221名[55.3%]女性；2名[0.5%]亚洲人，47名[11.8%]黑人或非裔美国人，3名[0.8%]夏威夷原住民或其他太平洋岛民，345名[86.3%]白人和1名多种族个体[0.3%]；172名西班牙裔或拉丁裔个体[43.0%]）。缓解所有covid -19相关症状的中位时间在环奈德组为19.0天（95% CI, 14.0-21.0），在安慰剂组为19.0天（95% CI, 16.0-23.0）。到第30天，所有症状的缓解没有差异（优势比为1.28；95% CI为0.84-1.97）。接受环lesonide治疗的受试者随后因COVID-19相关原因急诊或住院的次数较少（优势比为0.18；95% CI为0.04-0.85）。研究期间没有参与者死亡。结论及相关性这项随机临床试验的结果表明，环奈德没有达到缩短时间以缓解所有covid -19相关症状的主要疗效终点。
IMPORTANCE Systemic corticosteroids are commonly used in treating severe COVID-19. However, the role of inhaled corticosteroids in the treatment of patients with mild to moderate disease is less clear.OBJECTIVE To determine the efficacy of the inhaled steroid ciclesonide in reducing the time to alleviation of all COVID-19-related symptoms among nonhospitalized participants with symptomatic COVID-19 infection.DESIGN, SETTING, AND PARTICIPANTS This phase 3, multicenter, double-blind, randomized clinical trial was conducted at 10 centers throughout the US and assessed the safety and efficacy of a ciclesonide metered-dose inhaler (MDI) for treating nonhospitalized participants with symptomatic COVID-19 infection who were screened from June 11, 2020, to November 3, 2020.INTERVENTIONS Participants were randomly assigned to receive ciclesonide MDI, 160 mu g per actuation, for a total of 2 actuations twice a day (total daily dose, 640 mu g) or placebo for 30 days.MAIN OUTCOMES AND MEASURES The primary end point was time to alleviation of all COVID-19-related symptoms (cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell) by day 30. Secondary end points included subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19.RESULTS A total of 413 participants were screened and 400 (96.9%) were enrolled and randomized (197 [49.3%] in the ciclesonide arm and 203 [50.7%] in the placebo arm; mean [SD] age, 43.3 [16.9] years; 221 [55.3%] female; 2 [0.5%] Asian, 47 [11.8%] Black or African American, 3 [0.8%] Native Hawaiian or other Pacific Islander, 345 [86.3%] White, and 1 multiracial individuals [0.3%]; 172 Hispanic or Latino individuals [43.0%]). The median time to alleviation of all COVID-19-related symptoms was 19.0 days (95% CI, 14.0-21.0) in the ciclesonide arm and 19.0 days (95% CI, 16.0-23.0) in the placebo arm. There was no difference in resolution of all symptoms by day 30 (odds ratio, 1.28; 95% CI, 0.84-1.97). Participants who were treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons related to COVID-19 (odds ratio, 0.18; 95% CI, 0.04-0.85). No participants died during the study.CONCLUSIONS and RelevanceThe results of this randomized clinical trial demonstrated that ciclesonide did not achieve the primary efficacy end point of reduced time to alleviation of all COVID-19-related symptoms.